Vedolizumab in der Behandlung der Colitis ulcerosa und des Morbus Crohn – ein Konsensus der Arbeitsgruppe „Chronisch Entzündliche Darmerkrankungen“ der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

G. Novacek; C. Dejaco; H. P. Gröchenig; C. Högenauer; P. Knoflach; W. Miehsler; A. Moschen; W. Petritsch; H. Vogelsang; H. Tilg

doi:10.1055/s-0042-103694

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

Z Gastroenterol 2016; 54(05): 456-467
DOI: 10.1055/s-0042-103694

Mitteilungen

Vedolizumab in der Behandlung der Colitis ulcerosa und des Morbus Crohn – ein Konsensus der Arbeitsgruppe „Chronisch Entzündliche Darmerkrankungen“ der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

G. Novacek

¹Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Wien, Austria

,

C. Dejaco

¹Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Wien, Austria

,

H. P. Gröchenig

²Abteilung für Innere Medizin, Krankenhaus der Barmherzige Brüder, St. Veit an der Glan, Austria

,

C. Högenauer

³Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Graz, Austria

,

P. Knoflach

⁴1. Interne Abteilung, Klinikum Wels, Austria

,

W. Miehsler

⁵Abteilung für Innere Medizin, Krankenhaus der Barmherzigen Brüder Salzburg, Austria

,

A. Moschen

⁶Universitätsklinik für Innere Medizin I, Medizinische Universität Innsbruck, Austria

,

W. Petritsch

³Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Graz, Austria

,

H. Vogelsang

¹Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Wien, Austria

,

H. Tilg

⁶Universitätsklinik für Innere Medizin I, Medizinische Universität Innsbruck, Austria

Literatur
1 Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med 2011; 365: 1713-1725
2 Baumgart DC, Sandborn WJ. Crohn's disease. Lancet 2012; 380: 1590-1605
3 Dignass A, Lindsay JO, Sturm A et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis: current management. J Crohns Colitis 2012; 6: 991-1030
4 Dignass A, Van Assche G, Lindsay JO et al. The second European evidence-based consensus on the diagnosis and management of Crohn's disease: current management. J Crohns Colitis 2010; 4: 28-62
5 Peyrin-Biroulet L, Ferrante M, Magro F et al. Results from the 2nd Scientific Workshop of the ECCO. I: impact of mucosal healing on the course of inflammatory bowel disease. J Crohns Colitis 2011; 5: 477-483
6 Sandborn WJ. Mucosal healing in inflammatory bowel disease. Rev Gastroenterol Disord 2008; 8: 271-272
7 Rutgeerts P, Sandborn WJ, Feagan BG et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462-2476
8 Sandborn WJ, van Assche G, Reinisch W et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012; 142: 257-265
9 Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541-1549
10 Colombel JF, Sandborn WJ, Rutgeerts P et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007; 132: 52-65
11 Peyrin-Biroulet L, Deltenre P, de Suray N et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2008; 6: 644-653
12 Keane J, Gershon S, Wise RP et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001; 345: 1098-1104
13 Beaugerie L, Brousse N, Bouvier AM et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet 2009; 374: 1617-1625
14 Lichtenstein GR, Abreu MT, Cohen R et al. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006; 130: 940-987
15 Sandborn WJ, Feagan BG, Marano C et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014; 146: 85-95
16 Sandborn WJ, Feagan BG, Marano C et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014; 146: 96-109
17 Sandborn WJ, Rutgeerts P, Enns R et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007; 146: 829-838
18 EMA. Entyvio, Summary of Product Characteristics. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002782/human_med_001751.jsp&mid=WC0b01ac058001d124 accessed: 2015/07/07
19 Austria Codex online. Fachinformation Entyvio® 300mg Pulver zur Herstellung einer Infusionslösung. www.pharmazie.com http://www.takeda.at/~/media/countries/at/files/fachinfos/fachinfo_entyvio_2014-05-22.pdf accessed: 2015/03/21
20 Novacek G, Dejaco C, Knoflach P et al. Adalimumab for the treatment of ulcerative colitis – a consensus report by the working group inflammatory bowel diseases of the Austrian Society of Gastroenterology and Hepatology. Z Gastroenterol 2014; 52: 204-211
21 Kump PK, Krause R, Steininger C et al. Recommendations for the use of faecal microbiota transplantation "stool transplantation": consensus of the Austrian Society of Gastroenterology and Hepatology (OGGH) in cooperation with the Austrian Society of Infectious Diseases and Tropical Medicine. Z Gastroenterol 2014; 52: 1485-1492
22 Abbas AK, Lichtman AHH, Pillai S (Hrsg) “Cellular and molecular immunology”. Saunders WB; 2012
23 Soler D, Chapman T, Yang LL et al. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther 2009; 330: 864-875
24 von Andrian UH, Engelhardt B. Alpha4 integrins as therapeutic targets in autoimmune disease. N Engl J Med 2003; 348: 68-72
25 Briskin M, Winsor-Hines D, Shyjan A et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol 1997; 151: 97-110
26 Arihiro S, Ohtani H, Suzuki M et al. Differential expression of mucosal addressin cell adhesion molecule-1 (MAdCAM-1) in ulcerative colitis and Crohn's disease. Pathol Int 2002; 52: 367-374
27 Bloomgren G, Richman S, Hotermans C et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med 2012; 366: 1870-1880
28 Yousry TA, Major EO, Ryschkewitsch C et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med 2006; 354: 924-933
29 Feagan BG, Rutgeerts P, Sands BE et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369: 699-710
30 Feagan B, Sandborn WJ, Smyth M et al. Effects of continued vedolizumab therapy for ulcerative colitis in week 6 induction therapy nonresponders. J Crohns Colitis 2014; 8: S276-S277
31 An open-label study of vedolizumab (MLN0002) in patients with ulcerative colitis and Crohn's disease (GEMINI LTS). NCT00790933 https://clinicaltrials.gov/ct2/show/NCT00790933 accessed: 2015/08/03
32 Sands B, Dubinsky M, Vermeire S et al. Effects of increased vedolizumab dosing frequency on clinical remission and response in ulcerative colitis and Crohn's disease. Inflamm Bowel Dis 2014; 20: S67
33 Sands BE, Dubinsky MC, Vermeire S et al. Effects of increased vedolizumab dosing frequency on disease activity in ulcerative colitis and Crohn's disease. United European Gastroenterol J 2014; 2: A67
34 Sands B, Feagan B, Rutgeerts P et al. Vedolizumab induction therapy for patients with Crohn's disease and prior anti-tumour necrosis factor antagonist failure: a randomised, placebor-controlled, double-blind, multicentre trial. J Crohns Colitis 2013; 7: S5-S6
35 Feagan B, Rutgeerts P, Sands B et al. Vedolizumab maintenance therapy for ulcerative colitis: results of GEMINI I, a randomized, placebo-controlled, double-blind, multicenter, phase 3 trial. Am J Gastroenterol 2012; 107 (Suppl. 01) S609
36 Feagan B, Sands B, Sankoh S et al. Efficacy of vedolizumab in ulcerative colitis by prior treatment failure in GEMINI I, a randomised, placebo-controlled, double-blind, multi-centre trial. J Crohns Colitis 2013; 7: S216
37 Panaccione R, Ghosh S, Middleton S et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology 2014; 146: 392-400
38 Colombel JF, Siegel CA, Abhyankar B et al. Safety of vedolizumab alone or with concomitant corticosteroids and/or immunosuppressants with ulcerative colitis or Crohn's disease. United European Gastroenterol J 2014; 2: A82
39 Feagan BG, Greenberg GR, Wild G et al. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med 2005; 352: 2499-2507
40 Parikh A, Leach T, Wyant T et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis 2012; 18: 1470-1479
41 Rosario M, Dirks NL, Gastonguay MR et al. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther 2015; 42: 188-202
42 Reinisch W, Lewis JD, Dassopoulos T et al. Clinical response and remission with vedolizumab across a range of baseline fecal calprotectin levels in ulcerative colitis: results from GEMINI I. J Crohns Colitis 2015; 9: S47
43 Parikh A, Fox I, Leach T et al. Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. Inflamm Bowel Dis 2013; 19: 1691-1699
44 Feagan B, Kaser A, Smyth M et al. Long-term efficacy of vedolizumab therapy for patients with ulcerative colitis. Am J Gastroenterol 2014; 109: S477-S478
45 Feagan B, Kaser A, Smyth M et al. Long-term efficacy of vedolizumab therapy for ulcerative colitis. United European Gastroenterology J 2014; 2: A66-A67
46 Dignass A, Eliakim R, Magro F et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis. J Crohns Colitis 2012; 6: 965-990
47 Sandborn WJ, Feagan BG, Rutgeerts P et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013; 369: 711-721
48 Sandborn WJ, Feagan B, Reinisch W et al. P497 Efficacy of continued vedolizumab therapy in patients with Crohn's disease who did not respond to vedolizumab induction therapy at week 6. J Crohns Colitis 2014; 8: S274-S275
49 Sands BE, Colombel JF. the GEMINI II Working Group. Vedolizumab induction therapy for Crohn’s disease: results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter, phase 3 trial. United European Gastroenterology Week 2012; OP280
50 Colombel JF. the GEMINI II Working Group. Vedolizumab maintenance therapy for Crohn's disease: results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial. United European Gastroenterology Week 2012; OP139
51 Sands BE, Feagan BG, Rutgeerts P et al. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology 2014; 147: 618-627
52 Colombel JF, Sandborn WJ, Reinisch W et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383-1395
53 Sandborn WJ, Feagan BG, Rutgeerts P et al. Vedolizumab as induction and maintenance therapy for Crohn's disease – supplementary appendix. N Engl J Med 2013; 369: 711-721
54 Sandborn W, Reinisch W, Loftus Jr EV et al. Effect of vedolizumab on health-related quality of life (HRQoL) in patients with Crohn's disease. J Crohns Colitis 2015; 9: S227
55 Hanauer S, Rutgeerts P, Xu J et al. Long-term efficacy of vedolizumab therapy for Crohn's disease. United European Gastroenterology J 2014; 2: A66
56 Sands BE, Cohen R, Isaacs K et al. Infusion-related reactions with vedolizumab treatment in patients with UC or CD during the GEMINI 1 and GEMINI 2 clinical trials. J Crohns Colitis 2015; 9: S392-S393
57 Yajnik V, Khan N, Dubinsky M et al. Efficacy and safety of vedolizumab with advancing age in patients with ulcerative colitis: results from the GEMINI 1 study. J Crohns Colitis 2015; 9: S363-S364
58 Yajnik V, Khan N, Dubinsky M et al. Efficacy and safety of vedolizumab with advancing age in patients with Crohn's disease: results from the GEMINI 2 study. J Crohns Colitis 2015; S244-S245
59 Rosario M, Wyant T, Milch C et al. Pharmacokinetics, pharmacodynamics, and immunogenicity of vedolizumab in adults with inflammatory bowel disease. J Crohns Colitis 2014; 8: S42-S43
60 ÖGGH. Checkliste TNF-alpha-Blocker. http://www.oeggh.at/images/stories/pdf2 / checkliste_antitnfalpha_antikoerper2011.pdf accessed: 2015/07/14
61 FDA. Briefing document for the joint meeting of the gastrointestinal drugs advisory committee and drug safety and risk management advisory committee. Vedolizumab for the treatment of ulcerative colitis and Crohn's disease. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM377621 accessed: 2015/03/22
62 Dubinsky M, Mahadevan U, Vermeire S et al. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. J Crohns Colitis 2015; 9: S361-S362
63 Ebrahimi N, Herbstritt S, Gold R et al. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler 2015; 21: 198-205
64 Haghikia A, Langer-Gould A, Rellensmann G et al. Natalizumab use during the third trimester of pregnancy. JAMA Neurol 2014; 71: 891-895
65 Chan AC, Carter PJ. Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol 2010; 10: 301-316
66 Wyant T, Yang L, Fedyk E. In vitro assessment of the effects of vedolizumab binding on peripheral blood lymphocytes. mAbs 2013; 5: 842-850
67 Takeda Pharmaceuticals America Inc. Entyvio package insert. www.entyvio.com accessed: 2015/07/14
68 Wyant T, Leach T, Sankoh S et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut 2015; 64: 77-83